跳至主要内容
临床试验/NCT07181512
NCT07181512招募中不适用

Deep Learning-Based Opportunistic Screening of Coronary Artery Disease on Non-Contrast Chest CT: A Multicenter Study

Yifan Guo2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Accuracy of plaque composition prediction

研究概览

简要总结

Coronary artery disease (CAD) is one of the leading causes of death worldwide. Many people have early atherosclerosis without symptoms, and some may develop significant coronary stenosis before any warning signs appear. Identifying high-risk individuals at an early stage is important to prevent heart attacks and other cardiovascular events.

Coronary CT angiography (CCTA) can directly evaluate plaque type and the degree of narrowing in the coronary arteries, but it is expensive, requires contrast injection, and involves higher radiation, making it unsuitable for large-scale screening. In contrast, non-contrast chest CT is widely used for health check-ups and lung disease follow-up. Such scans often provide clear views of certain coronary segments, which creates an opportunity to screen for CAD without additional cost or risk.

This multicenter study aims to develop and validate deep learning models to analyze coronary calcified segments that are visible on non-contrast chest CT. Two main objectives are: (1) to predict whether calcified segments contain mixed plaque components (both calcified and non-calcified); and (2) to predict whether these segments have significant narrowing (≥50% stenosis) as determined by CCTA. The study will also describe how often ≥50% stenosis is found in non-calcified segments, in order to demonstrate their low-risk nature.

The study includes retrospective data collected between 2015 and 2024, and a prospective external validation cohort starting in 2025. Approximately 1,417 patients with paired chest CT and CCTA have already been included for model development and testing. An additional 200 or more patients will be prospectively recruited for external validation.

This research may provide evidence that deep learning applied to routine non-contrast chest CT can serve as an opportunistic tool for early CAD risk screening in the general population.

详细描述

This study involves analysis of imaging data obtained from patients who undergo non-contrast chest CT and CCTA as part of their routine clinical care. No additional imaging, radiation, or intervention is performed. The institutional review board approved the study and waived the requirement for written informed consent due to minimal risk and use of de-identified data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age ≥18 years
  • •Patients who underwent both non-contrast chest CT and coronary CT angiography (CCTA) within 30 days
  • •Coronary segments clearly visualized on non-contrast chest CT

排除标准

  • •Segments with motion artifacts, metal artifacts, or stents preventing analysis
  • •Vessel lumen completely obscured by calcification (unrecognizable vascular course)
  • •Inability to match coronary segment location between non-contrast chest CT and CCTA

研究组 & 干预措施

Patients undergoing non-contrast chest CT and CCTA

A cohort of patients who underwent both non-contrast chest CT and coronary CT angiography (CCTA) within 30 days. Clearly visualized coronary segments will be analyzed at the segment level for plaque composition and ≥50% stenosis using deep learning models. Both retrospective (2015-2024) and prospective (2025) cases are included.

干预措施: Deep Learning Analysis of Non-contrast Chest CT (Other)

结局指标

主要结局

Accuracy of plaque composition prediction

时间窗: Baseline non-contrast chest CT to reference CCTA (within 30 days)

Discrimination ability of the deep learning model to classify calcified coronary segments as purely calcified or mixed plaque, using CCTA as the reference standard. Evaluated with AUC, sensitivity, specificity.

Accuracy of ≥50% stenosis prediction

时间窗: Baseline non-contrast chest CT to reference CCTA (within 30 days)

Discrimination ability of the deep learning model to predict ≥50% luminal stenosis in calcified coronary segments, using CCTA as the reference standard. Evaluated with AUC, sensitivity, specificity, PPV, NPV.

次要结局

  • Incidence of ≥50% stenosis in non-calcified segments(Baseline non-contrast chest CT to CCTA (within 30 days))

研究者

发起方
Yifan Guo
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Yifan Guo

Lecturer, Department of Radiology, First Affiliated Hospital of Zhejiang Chinese Medical University

Zhejiang Chinese Medical University

研究点 (2)

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